ABBRIVIATED NEW DRUG PPLICATION (ANDA)

SEMINAR ON:. ABBRIVIATED NEW DRUG PPLICATION (ANDA). Presented by: Nagori Stavan Arunkumar Department of Pharmaceutics L.M.College of Pharamcy. ANDA. Pool of topics:. Introduction History of ANDA Guidelines available for ANDA Filling of ANDA

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ABBRIVIATED NEW DRUG PPLICATION (ANDA)

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1. SEMINAR ON: ABBRIVIATED NEW DRUG PPLICATION (ANDA) Presented by: Nagori Stavan Arunkumar Department of Pharmaceutics L.M.College of Pharamcy
2. ANDA Pool of topics: • Introduction • History of ANDA • Guidelines available for ANDA • Filling of ANDA • Manufacturing and control requirements of the ANDA • 180 days exclusitivity under Hatch Waxman amendment • Concept of Paragraph I to IV • Substantially complete ANDA • House keeping regulation • Patent expiration regulation • Triggering period • Waivers of exclusitivity • 505(b)(2) application • Supplemental new drug applications • Case studies • List of ANDA approved • 2006 pending ANDA • ANDA filed by or with Indian Pharmaceutical company • List of references
3. ANDA 1. Introduction ANDA contains data submitted to FDA's Center for Drug evaluation and Research, Office of Generic Drugs, for review and ultimate approval of a generic drug product. Once ANDA is approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
4. ANDA • All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). • Generic drug applications are termed "abbreviated" • Use of bioequivalence as the base for approving generic drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the WAXMAN-HATCH ACT.
5. ANDA 2. HISTORY OF ANDA: • In 1938, proof of safety • In 1962, “THE KEFAUVER HARIS AMENDMENTS” • “THE KEFAUVER HARIS AMENDMENTS” led to “DRUG EFFICACY STUDY IMPLEMENTATION (DESI)”. • FDA’s realization • Mid 1966 notice in federal Register • DESI review ultimately led to evolution of ANDA concept.
6. ANDA • On April 24th 1970, the ANDA policy was published with exception of DESI pending list drugs and exempt as per court order • In November 1984, The Drug Price Competition and Patent Term Restoration Act. • Title 1: ANDA regardless of time before or after 1962 • Title 2: Patent extension for life lost • Title 3: Textile and wood products • In April, 1992 FDA finalized the regulations outlining the requirements for ANDAs.
7. ANDA • On November 21, 1997 Modernization Act was signed. • Section 506A-Changes for approved ANDA/NDA • Hatch-Waxman Amendments
8. ANDA 3. GUIDELINES AVAILABLE FOR ANDA: • Guidelines describe format & content for the following sections. • Application summary • Chemistry, Manufacturing and controls section • Non clinical pharmacology and toxicology section • Human pharmacokinetics & bioavailability section • Clinical and statically section • Microbiology section
9. ANDA • Guidelines available for ANDA includes: • Organization of ANDA • Electronic submission of data for ANDA • Submission of archival copy of application in Microfiche • Guideline for impurities in drug substances • Guideline for submitting supporting documentation for the Manufacture of Drug substance. • Guideline for submitting supporting documentation for the Manufacture of finished dosage forms.
10. ANDA • Guideline for submitting supporting documentation for stability studies of Human drugs and Biologics. • Guideline for packaging • Guidelines for changes in approved ANDA and NDA • Variations in Drug Products that may be included in a single ANDA • 180 days exclusivity under Hatch Waxman amendment • Guidelines for alternate source of API in pending ANDAs • Post marketing reporting of Adverse Drug reactions • Guidelines for changes in approved ANDA and NDA
11. ANDA 4. FILING OF ANDA:
12. ANDA • Proper organization • Proper format, clear table of contents, correct folders (jackets), correct tabulation and pagination • Detail’s under 21 CFR 314.50, 21 CFR 314.94 and 21 CFR 314.440 • OGD’s recommendation of bioequivalence, chemistry and labeling portions of an application
13. ANDA Paper based filing of ANDA: • Application copies and general format: • Submit Archival (reference, retained and official approved copy) and filed copy (duplicate, used by FDA investigators) in english • Translation copy with original reference copy
14. ANDA • Review copy (duplicate, FDA viewer, destroyed) in 2 sets of binders (jackets) • In first binder CMC • In another BE data • Remaining data (table of contents, labeling) in both • Consistency in color coding binders, volume size and specifications, size and quality of paper
15. ANDA
16. ANDA
17. ANDA II. Cover letter: • Purpose of submission • Type of submission (ANDA, amendment, supplement, annual report, or resubmission of a previously withdrawn application) • Name, title, address and signature of applicant • Proprietary name (if any) and name of drug product • Number of volumes submitted • Commitment to resolution of any issues identified in the methods validation process after approval • Statement that the application or a portion of the submission is in electronic process after approval • Clearly identify submissions that contain sterility assurance data
18. ANDA III. Table of content<(21 CFR 314509B)>:

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